NCT04293640

Brief Summary

Investigating neural respiratory drive by examining parasternal EMG measurements in patients presenting for assessment of presumed pulmonary hypertension.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

February 20, 2020

Last Update Submit

March 2, 2020

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change in neural respiratory drive

    Electromyogram (EMG) signals during tidal breathing as a proportion of EMG signals from maximal manoeuvre. Measured at baseline and again 3 months after commencing treatment.

    3 months

Secondary Outcomes (1)

  • Cross sectional assessment of neural respiratory drive

    Baseline test

Interventions

Parasternal electromyogram measurementDIAGNOSTIC_TEST

Three electrodes are applied to the chest (two to parasternal muscles, one reference electrode to clavicle). Measurements of EMG signals are recorded on appropriate software.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to Scottish Pulmonary Vascular Unit for investigation of pulmonary hypertension.

You may qualify if:

  • Able to give informed consent
  • Being investigated for pulmonary hypertension

You may not qualify if:

  • Patient is pregnant
  • Patient has a diagnosed neuromuscular disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golden Jubilee National Hospital

Glasgow, G81 4DY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Martin Johnson

    NHS Greater Glasgow and Clyde

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Johnson

CONTACT

01419515000mjohnson4@nhs.net

Paul McCaughey

CONTACT

07907029041paulmccaughey@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

March 3, 2020

Study Start

February 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

March 3, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)